Regulatory Affairs Manager
SoClean, originally known for its popular sleep equipment maintenance device, the SoClean 2, offers a whole line of health technology products. SoClean’s innovative line of products does the dirty work, so you can take the best possible care of yourself and your family. The company is headquartered in Peterborough, NH and has another facility located in Kalispell, Montana. SoClean was founded on the principles of collaboration, and we have created a space that reflects that culture. The concept of our original product was developed through employee brainstorming sessions to meet a compelling healthcare need. As we grew, we maintained our focus on culture, the team, and the customer. You can see it and feel it when entering one of our facilities. Whether it’s a customer care representative providing advice while walking through the call center on wireless headphones or an impromptu meeting on comfy seating, it becomes clear that SoClean walks the walk of an employer of choice. Come experience it for yourself.
The Regulatory Affairs Manager ensures all aspects of SoClean medical device development comply with US and international regulations for marketing and sale. The candidate will represent SoClean as the primary interface to all applicable regulatory and compliance agencies as well as being responsible for the preparation, monitoring and communication of regulatory affairs status to the SoClean management team.
- Develop regulatory strategies to support operational objectives for US and international marketing and sale.
- Provide regulatory guidance to the company throughout the product life-cycle.
- Clearly communicate regulatory timelines and milestones to the development team and program management.
- Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions.
- Specify and coordinate product and distribution labelling with the development and operations teams.
- Review marketing material for appropriate labelling and claims: IFU, internet, audio and video media.
- Review new and modified devices for fulfillment of regulatory obligations: FDA, European MDD/MDR, CE, PMDA, and Canadian CMDR.
- Review new and modified devices for fulfillment of appropriate standards for electrical, mechanical, material and software safety: ISO, UL, IEC.
- Collaborate with appropriate departments for developing applicable materials need to gain market clearance.
- Prepare regulatory documents required for timely completion of regulatory submissions that could include some or all of the following: pre-submissions, PMA, 510(k), IDE and technical file for Notified Body.
- Prepare regulatory non-filing justifications, as required.
- Maintain appropriate domestic and international registrations and product listings.
- Support post-market corrective actions.
- Compile all documentation needed for annual reporting and approval supplements.
- Support relevant regulatory and compliance training activities for company employees.
- Provide assistance as needed with corporate regulatory compliance.
- Assist with the design, update, and adherence to standard operating procedures to meet regulatory standards.
- All other duties, as assigned.
- Bachelor’s Degree – preferably in Life Sciences or Engineering disciplines
- Minimum 5 years medical device industry experience in a regulatory affairs role
- Thorough understanding of medical device agency regulations: FDA’s medical device regulation (21 CFR Part 820), CE, European MDD/MDR, PMDA, CMDR
- Working knowledge of applicable medical device standards. E.g.: ISO 13485, ISO 14971, IEC 60601, IEC 62304.
- Experience developing successful regulatory strategies.
- Experience interfacing directly with the FDA, international regulatory agencies and notified bodies.
- Experience specifying and reviewing product labelling.
- Ability to identify and work with external regulatory consultants.
- Strong leadership and interpersonal communication skills.
- Self-motivated with a proactive attitude and the ability to work independently.
- Strong problem-solving and decision-making skills.
- Strong written and oral communication skills.
- Strong organizational skills.
- Team oriented.
- Computer proficiency (MS Word, Excel, PowerPoint, Outlook, SharePoint programs).
Location & Travel
The position’s preferred location is in Peterborough, NH. Some travel may be required in the future once the pandemic is over.
Competitive salary & excellent benefits.
For immediate consideration, submit cover letter and resume.
SoClean, Inc. is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Learn more here
Job posted: 2020-12-16